BurnschestburnNCT05603507
Inspiratory Muscle Training in Children With Chest Burn
A study testing inspiratory muscle training and pulmonary rehabilitation in people with Burns and Respiratory Function Impaired, run by Qassim University at 1 site in Saudi Arabia.
Trial summary
8 weeks of inspiratory muscle training combined with a pulmonary rehabilitation program increases respiratory muscle strength, pulmonary function, functional capacity, and quality of life in chest burned children. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Burns, Respiratory Function Impaired, Children
- What is being tested?
- inspiratory muscle training and pulmonary rehabilitation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 10 Sep 2021to 15 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children aged 10 to 18.
- Following hospital discharge.- Total body surface area (TBSA) of 30% to 50%.
- Chest burns.
- Deep partial to full thickness burns.
- Subjects who had a skin graft or who healed completely were also included.
Who cannot join
- - Participants who had a nonhealing or open wound.
- Congenital diaphragmatic hernia.
- Chest wall deformity.
- Cardiac or pulmonary problems.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Outpatient Clinic of College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University
Al Kharj, Riyadh Region, 11432
About this study
Official title: Inspiratory Muscle Training Effects on Pulmonary Function and Quality of Life in Children With Chest Burn
8 weeks of inspiratory muscle training combined with a pulmonary rehabilitation program increases respiratory muscle strength, pulmonary function, functional capacity, and quality of life in chest burned children.
Read the detailed description
The primary purpose of this study is to see how an inspiratory muscle training program along with a pulmonary rehabilitation program improved respiratory muscle strength, respiratory function and quality of life after children with chest burns were discharged from the hospital.
- Conditions
- Burns, Respiratory Function Impaired, Children
- Being tested
- inspiratory muscle training, pulmonary rehabilitation
- Keywords
- chest burn, respiratory muscle strength, lung function
- Medical subject headings
- Burns, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inspiratory muscle trainingOther
Also called inspiratory resistance
training done with a pressure threshold-loading device
pulmonary rehabilitationOther
Also called Aerobic and resistance training
Circuit training of aerobic and resistive exercise
| Study group | Role | What they receive |
|---|---|---|
| inspiratory muscle training group | Experimental | received both inspiratory muscle training and pulmonary rehabilitation Receives: Other: inspiratory muscle training; Other: pulmonary rehabilitation |
| pulmonary rehabilitation group | Sham comparator | received only pulmonary rehabilitation and sham inspiratory muscle training Receives: Other: pulmonary rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximal inspiratory pressure
performed using an electronic respiratory pressure meter
Measured: 1 week after hospital discharge
maximal inspiratory pressure
performed using an electronic respiratory pressure meter
Measured: 8 weeks
maximal expiratory pressure
performed using an electronic respiratory pressure meter
Measured: 1 week after hospital discharge
maximal expiratory pressure
performed using an electronic respiratory pressure meter
Measured: 8 weeks
Pulmonary function test, forced expiratory volume in the first second
performed using a spirometer, the FEV1 (forced expiratory volume in the first second) was recorded.
Measured: 1 week after hospital discharge
Pulmonary function test, forced expiratory volume in the first second
performed using a spirometer, the FEV1 (forced expiratory volume in the first second) was recorded.
Measured: 8 weeks
Pulmonary function test, forced vital capacity
performed using a spirometer, the FVC (forced vital capacity) was recorded.
Measured: 1 week after hospital discharge
Pulmonary function test, forced vital capacity
performed using a spirometer, the FVC (forced vital capacity) was recorded.
Measured: 8 weeks
Pulmonary function test, FEV1/FVC ratio
performed using a spirometer, (forced expiratory volume in the first second/ forced vital capacity) FEV1/FVC ratio was recorded.
Measured: 1 week after hospital discharge
Pulmonary function test, FEV1/FVC ratio
performed using a spirometer, (forced expiratory volume in the first second/ forced vital capacity) FEV1/FVC ratio was recorded.
Measured: 8 weeks
Secondary outcomes (4)
Functional exercise capacity
assessed using the six-minute walk test
Measured: 1 week after hospital discharge
Functional exercise capacity
assessed using the six-minute walk test
Measured: 8 weeks
Health related Quality of Life
assessed using the validated cross-culturally adapted version of the Pediatric Quality of life, The Peds-QL is a 23-item scale. Participants scored on a 5-point Likert scale ranging from 0 (never an issue) to 4 (almost always a problem). Following that, the item scores are decoded and linearly transformed to a 100-point scale. The psychosocial functioning summary score and physical functioning summary score were used for this study. A score of 100 indicates the highest functional status, while a score of 0 indicates the lowest functional status.
Measured: 1 week after hospital discharge
Health related Quality of Life
assessed using the validated cross-culturally adapted version of the Pediatric Quality of life, The Peds-QL is a 23-item scale. Participants scored on a 5-point Likert scale ranging from 0 (never an issue) to 4 (almost always a problem). Following that, the item scores are decoded and linearly transformed to a 100-point scale. The psychosocial functioning summary score and physical functioning summary score were used for this study. A score of 100 indicates the highest functional status, while a score of 0 indicates the lowest functional status.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start10 Sep 2021
- Primary completion9 Apr 2022
- Study completion15 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qassim University
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University, Prince Sattam Bin Abdulaziz University
- Responsible party
- Principal investigator, Maged Basha, Qassim University
- Investigators
- Ragab Elnaggar, PhD, Study chair, Prince Sattam Bin Abdulaziz UniversityAlshimaa Azab, PhD, Study director, Prince Sattam Bin Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05603507
- Sponsor's protocol ID
- RHPT/0020/0082
- Acronym
- chestburn
- Status last verified
- Oct 2022
- First submitted
- 26 Oct 2022
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
Publications
Willis CE, Grisbrook TL, Elliott CM, Wood FM, Wallman KE, Reid SL. Pulmonary function, exercise capacity and physical activity participation in adults following burn. Burns. 2011 Dec;37(8):1326-33. doi: 10.1016/j.burns.2011.03.016. Epub 2011 May 6.
PubMed 21530086Laszlo G. Standardisation of lung function testing: helpful guidance from the ATS/ERS Task Force. Thorax. 2006 Sep;61(9):744-6. doi: 10.1136/thx.2006.061648.
PubMed 16936234
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inspiratory Muscle Training Effects on Pulmonary Function and Quality of Life in Children With Chest Burn
- ClinicalTrials.gov ID
- NCT05603507
- Acronym / sponsor ID
- chestburn / RHPT/0020/0082
- Conditions
- Burns, Respiratory Function Impaired, Children
- Keywords
- chest burn, respiratory muscle strength, lung function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Qassim UniversityUniversity, hospital or other
- Collaborators
- Cairo University, Prince Sattam Bin Abdulaziz University
- Study start
- 10 Sep 2021 (actual)
- Primary completion
- 9 Apr 2022 (actual)
- Study completion
- 15 May 2022 (actual)
- First posted
- 2 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
8 weeks of inspiratory muscle training combined with a pulmonary rehabilitation program increases respiratory muscle strength, pulmonary function, functional capacity, and quality of life in chest burned children.
Detailed description
The primary purpose of this study is to see how an inspiratory muscle training program along with a pulmonary rehabilitation program improved respiratory muscle strength, respiratory function and quality of life after children with chest burns were discharged from the hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| inspiratory muscle training group | Experimental | Other: inspiratory muscle training, Other: pulmonary rehabilitationreceived both inspiratory muscle training and pulmonary rehabilitation |
| pulmonary rehabilitation group | Sham comparator | Other: pulmonary rehabilitationreceived only pulmonary rehabilitation and sham inspiratory muscle training |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Children aged 10 to 18.
- Following hospital discharge.- Total body surface area (TBSA) of 30% to 50%.
- Chest burns.
- Deep partial to full thickness burns.
- Subjects who had a skin graft or who healed completely were also included.
Key exclusion criteria (4 listed)
- - Participants who had a nonhealing or open wound.
- Congenital diaphragmatic hernia.
- Chest wall deformity.
- Cardiac or pulmonary problems.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inspiratory muscle trainingAlso: inspiratory resistancetraining done with a pressure threshold-loading device | Other | inspiratory muscle training group |
| pulmonary rehabilitationAlso: Aerobic and resistance trainingCircuit training of aerobic and resistive exercise | Other | inspiratory muscle training group, pulmonary rehabilitation group |
Primary outcome
maximal inspiratory pressure
Time frame: 1 week after hospital discharge
performed using an electronic respiratory pressure meter
maximal inspiratory pressure
Time frame: 8 weeks
performed using an electronic respiratory pressure meter
maximal expiratory pressure
Time frame: 1 week after hospital discharge
performed using an electronic respiratory pressure meter
maximal expiratory pressure
Time frame: 8 weeks
performed using an electronic respiratory pressure meter
Pulmonary function test, forced expiratory volume in the first second
Time frame: 1 week after hospital discharge
performed using a spirometer, the FEV1 (forced expiratory volume in the first second) was recorded.
Pulmonary function test, forced expiratory volume in the first second
Time frame: 8 weeks
performed using a spirometer, the FEV1 (forced expiratory volume in the first second) was recorded.
Pulmonary function test, forced vital capacity
Time frame: 1 week after hospital discharge
performed using a spirometer, the FVC (forced vital capacity) was recorded.
Pulmonary function test, forced vital capacity
Time frame: 8 weeks
performed using a spirometer, the FVC (forced vital capacity) was recorded.
Pulmonary function test, FEV1/FVC ratio
Time frame: 1 week after hospital discharge
performed using a spirometer, (forced expiratory volume in the first second/ forced vital capacity) FEV1/FVC ratio was recorded.
Pulmonary function test, FEV1/FVC ratio
Time frame: 8 weeks
performed using a spirometer, (forced expiratory volume in the first second/ forced vital capacity) FEV1/FVC ratio was recorded.
4 secondary outcomes
Functional exercise capacity
Time frame: 1 week after hospital discharge
Functional exercise capacity
Time frame: 8 weeks
Health related Quality of Life
Time frame: 1 week after hospital discharge
Health related Quality of Life
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Background: PubMed 21530086Willis CE, Grisbrook TL, Elliott CM, Wood FM, Wallman KE, Reid SL. Pulmonary function, exercise capacity and physical activity participation in adults following burn. Burns. 2011 Dec;37(8):1326-33. doi: 10.1016/j.burns.2011.03.016. Epub 2011 May 6.
- Results publication: PubMed 16936234Laszlo G. Standardisation of lung function testing: helpful guidance from the ATS/ERS Task Force. Thorax. 2006 Sep;61(9):744-6. doi: 10.1136/thx.2006.061648.
- Individual participant dataSharing planned: Yes. The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ragab Elnaggar, PhD study chair
Prince Sattam Bin Abdulaziz University
Alshimaa Azab, PhD study director
Prince Sattam Bin Abdulaziz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inspiratory muscle training and pulmonary rehabilitation in people with Burns and Respiratory Function Impaired, run by Qassim University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maximal inspiratory pressure (time frame: 1 week after hospital discharge). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05603507, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2022.